A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton’s Tyrosine Kinase Inhibitor, in Patients with B-Cell Malignancies
Professor Chan Cheah
TG Therapeutics, Inc.
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Waldenstrom’s Macrogloblinemia
- Mantle Cell Lymphoma
- Follicular Lymphoma
- Diffuse Large B-cell Lymphoma
- Marginal Zone Lymphoma
Non-Hodgkin lymphomas are cancers of white blood cells that can be divided into indolent (slow growing) and aggressive (fast growing), though they share common pathways that can be targeted by anti-cancer drugs.
This trial is for patients who have Non-Hodgkin lymphoma or Chronic Lymphocytic Leukaemia which has returned after treatment or treatment naive patients unsuitable for chemotherapy. Patients will receive TG-1701 orally. It works by targeting an important part of the cancer cell called Bruton’s tyrosine kinase (BTK), which causes the cells to die.
Include, but not limited to, the following:
- Relapsed or refractory histologically confirmed B-cell lymphoma or CLL
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
- Adequate organ function
- Prior therapy with a BTK inhibitor (ibrutinib, acalabrutinib, other)
- Any major surgery, chemotherapy or immunotherapy within the last 21 days
- Hepatitis B virus, hepatitis C virus or HIV infection